Sr. Quality Enginee - Katalyst Healthcares & Life Sciences
Boston, MA 02108
About the Job
Responsibilities:
- Develop and implement quality plans and strategies aligned with project and organizational goals.
- Identify areas for improvement in manufacturing and engineering processes, applying methodologies like Six Sigma or Lean.
- Establish and maintain quality standards and procedures throughout the product lifecycle.
- Lead investigations into quality issues, conducting root cause analysis and implementing corrective actions.
- Conduct internal and external audits to ensure compliance with quality standards and regulations.
- Oversee testing and validation of products to ensure they meet specifications and customer requirements.
- Maintain accurate documentation of quality processes, test results, and compliance with regulatory requirements.
- Provide training and mentorship to junior quality engineers and other team members on quality practices.
- Work closely with cross-functional teams, including design, manufacturing, and supply chain, to drive quality initiatives.
- Collaborate with suppliers to ensure they meet quality standards and participate in supplier audits as needed.
- A minimum of 4-6 years of related experience.
- Must have Process Validation experience.
- Good technical understanding of manufacturing equipment and processes.
- Knowledge of statistical software packages (e.g. Minitab) with the ability to preview, graph and analyse data and be able to present data that facilitates/drives decision making.
- Experience working in both an FDA and European regulatory environment in manufacturing/operations.
- A thorough understanding of GMP/ISO regulations and validation regulations
- The ability to perform "hands on " troubleshooting and problem solving.
- Knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook).
- In-depth knowledge of product/process Risk Management (FDA and ISO standards).
- Strong communication and interpersonal skills.
- Must have the ability to function in a team-based manufacturing environment.
- The ability to collaborate with all levels of management in a cross-functional team environment.
Source : Katalyst Healthcares & Life Sciences
